Trial Outcomes & Findings for MethaCholine Bronchoprovocation Study (MeCIS) (NCT NCT00705341)
NCT ID: NCT00705341
Last Updated: 2013-02-12
Results Overview
Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
219 participants
Primary outcome timeframe
weeks 0, 4
Results posted on
2013-02-12
Participant Flow
Participant milestones
| Measure |
Asthmatic Controls for Phase 1
People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
|
Non Asthmatic Controls for Phase 1
People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
|
Low Dose, Then High Dose Fluticasone for Phase 2
People with asthma receive fluticasone at 250 mcg per day (28 days), then wash-out period (28 days), then fluticasone at 1000 mcg per day (28 days) in phase 2.
|
High Dose, Then Low Dose Fluticasone for Phase 2
People with asthma receive fluticasone at 1000 mcg per day 28 days), then wash-out period (28 days), fluticasone at 250 mcg per day (28 days) in phase 2.
|
|---|---|---|---|---|
|
Phase 1:Control Challenge
STARTED
|
126
|
93
|
0
|
0
|
|
Phase 1:Control Challenge
COMPLETED
|
126
|
93
|
0
|
0
|
|
Phase 1:Control Challenge
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 2: Trial
STARTED
|
0
|
0
|
30
|
32
|
|
Phase 2: Trial
COMPLETED
|
0
|
0
|
23
|
28
|
|
Phase 2: Trial
NOT COMPLETED
|
0
|
0
|
7
|
4
|
Reasons for withdrawal
| Measure |
Asthmatic Controls for Phase 1
People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
|
Non Asthmatic Controls for Phase 1
People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
|
Low Dose, Then High Dose Fluticasone for Phase 2
People with asthma receive fluticasone at 250 mcg per day (28 days), then wash-out period (28 days), then fluticasone at 1000 mcg per day (28 days) in phase 2.
|
High Dose, Then Low Dose Fluticasone for Phase 2
People with asthma receive fluticasone at 1000 mcg per day 28 days), then wash-out period (28 days), fluticasone at 250 mcg per day (28 days) in phase 2.
|
|---|---|---|---|---|
|
Phase 2: Trial
Withdrawal by Subject
|
0
|
0
|
6
|
4
|
|
Phase 2: Trial
Did not meet post-diluent threshold
|
0
|
0
|
1
|
0
|
Baseline Characteristics
MethaCholine Bronchoprovocation Study (MeCIS)
Baseline characteristics by cohort
| Measure |
Nonasthmatic Controls for Phase 1
n=93 Participants
People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
|
Asthmatic Controls for Phase 1
n=126 Participants
People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
33 years
STANDARD_DEVIATION 13 • n=5 Participants
|
38 years
STANDARD_DEVIATION 15 • n=7 Participants
|
35 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
126 participants
n=7 Participants
|
219 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weeks 0, 4Population: There was a significant period effect in the percentage change in post diluent baseline (PC20) for high- and low-dose depending upon the order in which the doses were administered. In order to remove the effect of the order, we compared the high- and low-dose MCT results exclusively during the first cross over.
Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks
Outcome measures
| Measure |
4 Weeks of High Dose Fluticasone
n=28 Participants
4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
|
4 Weeks of Low Dose Fluticasone
n=23 Participants
4 weeks of Fluticasone (Flovent diskus) 250 mcg once daily
|
|---|---|---|
|
Methacholine Challenge Test Result for Phase 2
|
1.19 mg/ml
Interval 0.1 to 26.92
|
2.04 mg/ml
Interval 0.16 to 48.0
|
SECONDARY outcome
Timeframe: one timePredictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls
Outcome measures
| Measure |
4 Weeks of High Dose Fluticasone
n=126 Participants
4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
|
4 Weeks of Low Dose Fluticasone
n=93 Participants
4 weeks of Fluticasone (Flovent diskus) 250 mcg once daily
|
|---|---|---|
|
Predictive Value of Methacholine Challenge Test for Phase 1
|
96 % predictive value
Interval 90.0 to 99.0
|
75 % predictive value
Interval 66.0 to 83.0
|
Adverse Events
Low Dose for phase1
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
High Dose for Phase 2
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose for phase1
n=30 participants at risk
4 weeks of Fluticasone (Flovent diskus) 250 mcg twice daily (500 mcg/day)
|
High Dose for Phase 2
n=32 participants at risk
4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
|
|---|---|---|
|
General disorders
headache
|
73.3%
22/30
Adverse events were not collected in phase 1 of the study
|
68.8%
22/32
Adverse events were not collected in phase 1 of the study
|
|
Respiratory, thoracic and mediastinal disorders
Oral candidiasis
|
6.7%
2/30
Adverse events were not collected in phase 1 of the study
|
9.4%
3/32
Adverse events were not collected in phase 1 of the study
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
76.7%
23/30
Adverse events were not collected in phase 1 of the study
|
68.8%
22/32
Adverse events were not collected in phase 1 of the study
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
60.0%
18/30
Adverse events were not collected in phase 1 of the study
|
59.4%
19/32
Adverse events were not collected in phase 1 of the study
|
|
Infections and infestations
Sinusitis
|
16.7%
5/30
Adverse events were not collected in phase 1 of the study
|
12.5%
4/32
Adverse events were not collected in phase 1 of the study
|
|
General disorders
Pharyngitis
|
43.3%
13/30
Adverse events were not collected in phase 1 of the study
|
46.9%
15/32
Adverse events were not collected in phase 1 of the study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
63.3%
19/30
Adverse events were not collected in phase 1 of the study
|
59.4%
19/32
Adverse events were not collected in phase 1 of the study
|
|
General disorders
Hoarseness/ dysphoria
|
40.0%
12/30
Adverse events were not collected in phase 1 of the study
|
50.0%
16/32
Adverse events were not collected in phase 1 of the study
|
|
Infections and infestations
Upper respiratory infection
|
23.3%
7/30
Adverse events were not collected in phase 1 of the study
|
18.8%
6/32
Adverse events were not collected in phase 1 of the study
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory inflammation
|
36.7%
11/30
Adverse events were not collected in phase 1 of the study
|
28.1%
9/32
Adverse events were not collected in phase 1 of the study
|
|
Infections and infestations
Viral lower respiratory infection
|
6.7%
2/30
Adverse events were not collected in phase 1 of the study
|
15.6%
5/32
Adverse events were not collected in phase 1 of the study
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
10.0%
3/30
Adverse events were not collected in phase 1 of the study
|
12.5%
4/32
Adverse events were not collected in phase 1 of the study
|
|
Gastrointestinal disorders
Gastrointestinal discomfort and pain
|
33.3%
10/30
Adverse events were not collected in phase 1 of the study
|
28.1%
9/32
Adverse events were not collected in phase 1 of the study
|
|
Infections and infestations
Viral gastrointestinal infection
|
3.3%
1/30
Adverse events were not collected in phase 1 of the study
|
3.1%
1/32
Adverse events were not collected in phase 1 of the study
|
|
Gastrointestinal disorders
Nausea and vomiting
|
26.7%
8/30
Adverse events were not collected in phase 1 of the study
|
15.6%
5/32
Adverse events were not collected in phase 1 of the study
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
4/30
Adverse events were not collected in phase 1 of the study
|
15.6%
5/32
Adverse events were not collected in phase 1 of the study
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
10/30
Adverse events were not collected in phase 1 of the study
|
31.2%
10/32
Adverse events were not collected in phase 1 of the study
|
|
Musculoskeletal and connective tissue disorders
Muscle injury
|
10.0%
3/30
Adverse events were not collected in phase 1 of the study
|
18.8%
6/32
Adverse events were not collected in phase 1 of the study
|
|
Infections and infestations
Influenza
|
6.7%
2/30
Adverse events were not collected in phase 1 of the study
|
12.5%
4/32
Adverse events were not collected in phase 1 of the study
|
|
Infections and infestations
Fever
|
20.0%
6/30
Adverse events were not collected in phase 1 of the study
|
18.8%
6/32
Adverse events were not collected in phase 1 of the study
|
|
Injury, poisoning and procedural complications
Injury
|
16.7%
5/30
Adverse events were not collected in phase 1 of the study
|
21.9%
7/32
Adverse events were not collected in phase 1 of the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place